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Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring

Primary Purpose

Panic Disorder

Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Biofeedback
Muscle Relaxation
Sponsored by
Chimei Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Panic disorder, cognitive behavior therapy, Internet

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The participant must fulfill DSM-IV criteria for panic disorder.
  2. The participant must be between 20 and 60 years of age.
  3. The participant must have the Panic Disorder Severity Scale(PDSS) score ≧8.
  4. If the participant is taking prescribed drugs for panic disorder, a) the dosage have to be constant for 6 weeks before starting treatment, and b) the participant have to agree to keep the dosage constant for 2 months after starting treatment.
  5. If the participant was already in therapy, the contact must have lasted at least 3 months and not be based on cognitive behavior therapy.
  6. All participants have access to a computer with an Internet connection.

Exclusion Criteria:

  1. The participant suffers from any other psychiatric disorder in immediate need of treatment.
  2. The participant fulfills DSM-IV criteria for major depression.
  3. The participant has epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic hypertension.
  4. The participant has alcoholism or substance dependence.

Sites / Locations

  • Chimei Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Muscle Relaxation

Muscle Relaxation with Biofeedback

Waiting-List

Arm Description

The patients of this arm practice on-line muscle relaxation every day.They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.

The patients of this arm practice on-line muscle relaxation with finger temperature biofeedback every day. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.

The patients of this arm waited for four weeks. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR (APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Impressions-Improvement(CGI) were performed by well-trained clinicians.

Outcomes

Primary Outcome Measures

Score Change of The Panic Disorder Severity Scale(PDSS)

Secondary Outcome Measures

Score Change of relaxation-rating

Full Information

First Posted
August 20, 2012
Last Updated
August 22, 2012
Sponsor
Chimei Medical Center
Collaborators
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT01671033
Brief Title
Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring
Official Title
Muscle Relaxation With Biofeedback Via Internet for Panic disorder-a Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Terminated
Why Stopped
The drop-out rate was too high.
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chimei Medical Center
Collaborators
National Cheng Kung University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
From the scarce literature it showed that computer/internet-aided cognitive behavior therapy (CBT) was superior to waitlist and placebo assignment across outcome measures, and the effects of computer/internet-aided CBT were equal to therapist-delivered treatment across anxiety disorders. The aim of this study is to evidence the effectiveness of internet-based relaxation with biofeedback treatment for panic disorder.
Detailed Description
All participants had access to a computer with an internet connection and received the treatment via internet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
Panic disorder, cognitive behavior therapy, Internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Muscle Relaxation
Arm Type
Experimental
Arm Description
The patients of this arm practice on-line muscle relaxation every day.They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.
Arm Title
Muscle Relaxation with Biofeedback
Arm Type
Experimental
Arm Description
The patients of this arm practice on-line muscle relaxation with finger temperature biofeedback every day. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.
Arm Title
Waiting-List
Arm Type
No Intervention
Arm Description
The patients of this arm waited for four weeks. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR (APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Impressions-Improvement(CGI) were performed by well-trained clinicians.
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Other Intervention Name(s)
finger temperature biofeedback
Intervention Description
Patients with panic disorder practice muscle relaxation with temperature biofeedback monitor, and send the temperature data to server via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.
Intervention Type
Behavioral
Intervention Name(s)
Muscle Relaxation
Intervention Description
Patients with panic disorder practice muscle relaxation via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.
Primary Outcome Measure Information:
Title
Score Change of The Panic Disorder Severity Scale(PDSS)
Time Frame
Baseline / Week 4/ Week 8/ Week12/ Week 16
Secondary Outcome Measure Information:
Title
Score Change of relaxation-rating
Time Frame
Baseline / Week 4/ Week 8/ Week 12/ Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant must fulfill DSM-IV criteria for panic disorder. The participant must be between 20 and 60 years of age. The participant must have the Panic Disorder Severity Scale(PDSS) score ≧8. If the participant is taking prescribed drugs for panic disorder, a) the dosage have to be constant for 6 weeks before starting treatment, and b) the participant have to agree to keep the dosage constant for 2 months after starting treatment. If the participant was already in therapy, the contact must have lasted at least 3 months and not be based on cognitive behavior therapy. All participants have access to a computer with an Internet connection. Exclusion Criteria: The participant suffers from any other psychiatric disorder in immediate need of treatment. The participant fulfills DSM-IV criteria for major depression. The participant has epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic hypertension. The participant has alcoholism or substance dependence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fong-Lin Jang, M.D.
Organizational Affiliation
Chimei Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Chimei Medical Center
City
Tainan
ZIP/Postal Code
70246
Country
Taiwan

12. IPD Sharing Statement

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Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring

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